WO2002028312A1 - Sub-urethral supporting assembly for treating female stress urinary incontinence - Google Patents

Sub-urethral supporting assembly for treating female stress urinary incontinence

Info

Publication number
WO2002028312A1
WO2002028312A1 PCT/FR2001/003027 FR0103027W WO0228312A1 WO 2002028312 A1 WO2002028312 A1 WO 2002028312A1 FR 0103027 W FR0103027 W FR 0103027W WO 0228312 A1 WO0228312 A1 WO 0228312A1
Authority
WO
Grant status
Application
Patent type
Prior art keywords
strip
means
assembly
comprises
needle
Prior art date
Application number
PCT/FR2001/003027
Other languages
French (fr)
Inventor
Michel Therin
Original Assignee
Sofradim Production
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0004Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
    • A61F2/0031Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra
    • A61F2/0036Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra implantable
    • A61F2/0045Support slings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743Type of operation; Specification of treatment sites
    • A61B2017/00805Treatment of female stress urinary incontinence

Abstract

The invention concerns a surgical assembly for supporting the urethra (1) in a woman, comprising a sub-urethral supporting tape (2) and a skin penetrating needle (3). The invention is characterised in that when combined: d) a composite strip (4) assembles at least both the sub-urethral supporting tape (2) and a flattened protective sheath (5) wherein said tape is arranged; e) the flattened sheath (5) comprises, lengthwise, two parts (51, 52) arranged on either side of a separation zone (6) wherein is provided cleavable linking means (7) between the two parts; f) the composite strip (4) comprises at each of its two ends (4a, 4b) a common part (81), for example a female part, of connecting means (8) capable of being locked and unlocked, while the proximal tip (31) of the skin penetrating needle (3) comprises another part (82), for example a male part, of said connection means (8).

Description

SET OF RETAINING URETHRAL SUB IN THE TREATMENT OF STRESS URINARY INCONTINENCE WOMEN The present invention relates to surgical treatment of stress urinary incontinence in women. More particularly, the invention relates to a surgical assembly for, after the intervention or operation, to support the urethra by means of a sub-urethral tape, of which both ends are each attached to an appropriate part of the body of the patient, for example the abdominal wall thereof. To this end, in general, the surgical assembly contemplated by the present invention comprises a retaining strip suburethral and a percutaneous passage needle, this needle for engaging and pulling the retaining strip suburethral . The present invention relates to a surgical assembly as defined above, to universal, in that it can be used regardless of the way first, and intervention technique used by the practitioner.

To this end, a surgical assembly according to the invention presents in combination the following features: a) it comprises a composite band which includes at least the retaining suburethral tape and a flat protective sheath, the said strip being arranged, for example freely, inside this sheath; b) the flat sheath comprises, along its length, two parts arranged on either side of a separation zone in which is arranged a breakable connecting means between said two parts; c) the composite web includes at each of its two ends one part, for example the same female part, a connecting means, locked and unlocked, while the proximal heel of the percutaneous passage needle comprises another part , for example a male part, of said connecting means.

For one of the channels selected by the surgeon, for example the high channel, the assembly further comprises and optionally a flat, flexible piece, atraumatic, joining two pieces of the retaining strip, obtained by transverse cutting of this last. And this connecting piece comprises two opposite gripping means of two adjacent ends of two pieces of the retaining strip respectively.

The present invention is now described with reference to the accompanying drawing, wherein: - Figure 1 shows a front view of a surgical assembly according to the invention,

- Figure 2 shows a side view of the surgical assembly illustrated in Figure 1,

- Figure 3 shows, in sectional view, a connection means with the percutaneous passage needle, belonging to the surgical assembly illustrated according to Figures 1 and 2,

- Figure 4 shows, in top view, a joining part of two pieces of the support strip, which may belong to one surgical assembly according to the invention, - Figure 5 represents a side view of the junction piece shown in Figure 7 with its two opposite gripping means in the open position,

- Figures 6 to 9 show the various stages of implementation or implementation of a surgical assembly according to the invention, by vaginally,

- Figures 10 to 13 show the different stages of setting up or implementation of a surgical assembly according to the invention, by a so-called mixed path,

- Figures 14 to 21 show the different stages of setting up or implementation of a surgical assembly according to invention, by the high way.

In accordance with Figures 1 to 3, a surgical assembly according to the invention comprises at least:

- a composite strip 4 having two ends 4a, 4b tapered, triangular, flat,

- and a needle 3 by percutaneous passage having a distal end 32 of penetration and a flattened proximal heel 31

The composite web 4 brings at least a strip 2 retaining suburethral, ​​two end pieces 9, and a flat protective sheath 5, within which the strip 2 is arranged freely, that is to say without be attached to the duct 5. the strip 2 comprises a retaining apertured tricot, preferably indémaillable obtained with monofilaments or multifilaments of a biocompatible synthetic material, for example polypropylene or polyester. The strip 2 is preferably formed from a knitted material macroporous.

The latter is for example an apertured knitted polypropylene monofilament having a size between 0.12 and 0.16 millimeter and composed of two layers formed by two threaded guide bars each one full-empty eye needle heddle hook, these two bars being displaced symmetrically open mesh according to the following scale:

- bar I: 01-12-32

- Bar II: 32-21-01

The strip 2 is cut to length in the warp direction of the knitted fabric. In the case of a width of 12 mm, it has the following characteristics:

- a tensile strength in the direction of 105N + chain. 20%

- an elongation at break in the warp direction of 92% _ + 20%,

- an elongation at 20N 36%

- a start tiling with 6N force and an elongation of 15%.

By "tiling", spontaneous winding means of the strip 2 on itself about its longitudinal axis under longitudinal tensile stress.

The strip 2présente interesting advantages, particularly low particulate emissions during its stretching and a curl which appears only as an important force (6N). All these aforementioned features do not affect the porosity of the strip 2.

The latter can also be performed in whole or in part by biological tissue or material, for example collagen.

The protective sheath 5, flattened, is obtained from a synthetic material with a low coefficient of friction, for example by

PTFE. This sheath 5 comprises, along its length, two parts 51 and 52 disposed on either side of a separation zone 6 in which is arranged a connecting means 7 breakable between said two parts.

The composite strip 4 comprises at each of its two ends 4a and 4b the same part, namely one female part 81, a connection means 8, locked and unlocked at will, while the proximal heel of the needle 31 3 percutaneous passage includes another portion, for example a male part 82, the same connecting means 8.

To this end, the flattened sheath 5 includes or incorporates, at its two ends, two end pieces 9, comprising or incorporating, on the outside of the sheath 5, each of the same female part 81 of the connecting means 8.

This connecting means 8 therefore comprises two elements, one male 82 located at each end 4a or 4b of the composite strip ,. And the other female 81, located on the proximal heel 31 of the needle 3, these two male and female elements being snap one into the other.

More precisely, as shown particularly by Figure 3, the proximal heel 31 of the needle through skin 3 is spatula, and each end piece 9 of the composite tape 4 comprises, outside of the flattened sheath 5, a slot 83 adapted to the penetration of the proximal heel tip 31 of the needle 3, with a means 84 of heel retainer 31, lockable or releasable manually. The proximal heel 31 of the needle 3 comprises a through slot 85 for the elastic penetration of the retention means 84. In accordance with Figure 1, and according to a particular embodiment, the breakable connecting means 7 consists of an outer sheath

71, adhesive, tear, for example by shearing, by means of a tab

72. This sleeve 71 brings together two inner ends 51a and 52a of the two parts 51 and 52 of the flattened sheath 5 respectively adjacent to the separation zone 6.

To the route of said high response, as described below, the surgical assembly further comprises a part 10 shown in Figures 4 and 5, suitable for joining two pieces 21 and 22 of the strip 2 of support (see Figures 18 to 21), obtained by transverse cutting of the latter. This part 10 of junction, atraumatic, flat and flexible, comprises two opposite gripping means, two adjacent ends 21a and 22a of two pieces 21 and 22 respectively. To this end, each gripping Average Rating 1 1 comprises, first clamping means 12 a or 21a end 22a (see Figures 18 to 21) of the strip 2 of support, consisting of two jaws 12a and 12b flat hinged along the same connecting line, and secondly means 13 stapling the same end, consisting of a pin 13a on one of the jaws 12b, to pass through the strip 2, and a head 13b disposed on the the other jaw 12a, snap on the pin 13a.

Three different modes of implementation or implementing the surgical assembly described above are now exposed, namely a mode called vaginal respectively, a mode called a mixed way and a mode called by high way. For each of these modes, one starts from the surgical assembly according to Figures 1 to 3, in its connected or locked position, wherein the needle 3 is connected with its proximal bead 31, with one of the end pieces 9, c that is to say at one end, for example 4a, the composite web 4, and, thanks to the connecting means 8 previously described. For Mode said vaginally, and with reference to Figures 6 to 9:

- introducing the needle 3 through the vagina 17, is made to penetrate the needle 3 from bottom to top, the patient's right side, bypassing the bladder 16; see Figure 6. - thus engages the composite strip 4 in the right path; cf Figure 7.

- disconnecting the needle 3 of the end 4a of the composite strip 4 to connect it to the end 4b of the same band; then is made to penetrate the needle 3 from bottom to top, the patient's left side, still bypassing the bladder 16; see Figure 8.

- thus engages the composite strip 4 in the left path; when the latter forms a loop outside of the vagina 17, is torn transversely by shearing the connecting means 7, to release the two parts 51 and 52 of the sheath 5; by pulling on the two end pieces 9, extract the two parts 51 and 52 of the sheath 5, and releasing the retaining strip 2, below the urethra 1. With respect to the mixed path, and by referring to figures 10 to 13:

- is made to penetrate the needle 3 from top to bottom, the patient's right side, bypassing the bladder 16, and emerging through the vagina 17; cf Figure 10;

- the composite strip is then engaged 4 in the straight path, by penetration of the needle 3 from bottom to top, left side, bypassing the bladder 16; cf Figure 11;

- thus engages the composite strip 4 in the left path; disconnecting the needle 3 of the composite strip 4; is torn transversely connecting means 7, by shearing of the outer sleeve 71, and extracted from the latter to the outside of the vagina 17 (see Figure 12);

- by pulling on the two end pieces 9, extract the two parts 51 and 52 of the sheath 5, and releasing the retaining strip 2 on its way.

As regards the high way, and with reference to Figures 14 to 21:

- is made to penetrate the needle 3 from top to bottom, the patient's right side, from the abdominal wall 15, bypassing the bladder 16, and emerging through the vagina 17 (see Figure 14);

- thus engages the composite strip 4 in the right path; where the binding means 7 is outside the vagina 17, cutting the composite strip 4 on both sides of the latter, so as to determine two parts, one part 41 remaining in the straight path, and a part 42 outside the vagina 17 (see Figure 15);

- is then made to penetrate the needle 3 connected to the portion 42 of the composite web 4, from top to bottom from the abdominal wall 15, the left side, bypassing the bladder 16 (see Figure 16); - thus engages the portion 42 of the composite strip 4 in the left path and then cutting the emerging part of the portion 42 of the composite strip 4, so as to separate the end piece 9 matching the rest of the web 4 (see Figure 17);

- by pulling on the ends 21a and 22a of the two strip retaining, it strips off the latter relative to both parts 52 and

51 respectively of the sheath 5; can thus have the junction piece 10, and proceed with the gripping of the two ends 21a and 22a (see Figure 18);

- the junction piece 10 thus combines, in a secure way, both ends 21a and 22a of the retaining strip 2 outside the vagina 17, as shown in Figure 19;

- then one proceeds to a suprapubic traction on the right portions 41 and left 42 of the composite strip 4, so as to bring the part 10 of junction suburethral position: then pulls on the two portions 52 and 51 of the sheath 4, so as to release the retaining strip 2; see figure 20.

- the strip 2 is thus in retropubic position and para-vesical, while the junction piece 10, atraumatic, is sub-urethral position (see Figure 21).

As described above, there is a surgical assembly according to the invention can be used regardless of the surgical approach and technique of intervention chosen by the surgeon.

Thanks to the invention, the strip 2 retaining can be released at the last moment, after verification of trips by cystoscopy.

If a wrong path, during the first pass and / or in the second pass, the interventional procedure remains reversible, either by disconnection of the needle 3 and pulling retrograde sheath 5, either by complete pulling of the composite web 4.

As the sheath 5 is not separated into its two parts 51 and 52, the surgical assembly according to the invention is reusable many times as necessary, until the desired path is achieved.

Claims

1 - to support the urethra surgical assembly (1) in women, comprising a strip (2) for sub-urethral support and a needle (3) of percutaneous passage, characterized, in combination: a) in that it comprises a composite band (4) that gathers at least the strip (2) of support under urethral and a sheath (5) of flattened protection, said strip (2) being arranged, for example freely, inside this sheath (5 ); b) the sheath (5) comprises flattened, along its length, two parts
(51, 52) arranged on either side of a separation zone (6) in which is arranged a connecting means (7) breakable between said two parts; c) the composite band (4) comprises at each of its two ends (4a, 4b) one portion (81), for example the same female part, a connecting means (8), locked and unlocked, while the proximal heel (31) of the needle (3) of percutaneous passage includes another portion (82), for example a male part, of said connecting means (8). 2 - assembly of claim 1, characterized in that the composite band (4) comprises two endpieces (9) comprising or incorporating each said same portion (81) of the connecting means (8).
3 - assembly of claim 1, characterized in that the connecting means (8) comprises two elements, one male (82) and the other female (81) snap into one another.
4 - assembly of claim 3, characterized in that the proximal heel (31) of the pin (3) skin is traversed and each spatula tip (9) of the flat sheath (5) comprises a slot (83) adapted for penetration of said spatula proximal heel (31), with retaining means (84) of said heel, lockable or releasable manually.
5 - assembly of claim 4, characterized in that the proximal heel (31) of skin crossing needle (3) comprises a through slot (85) for the penetration of the retention means (84).
6 - assembly according to claim 1, characterized in that the connecting means (7) scored, comprises an outer sheath (71) adhesive, e.g. tearable shear, bringing together the two inner ends (51a, 52a) of the two parts ( 51, 52) of the flat sheath (5) respectively adjacent to the separation zone (6).
7 - assembly of claim 1, characterized in that it further comprises a part (10) flat and flexible joining two pieces (21, 22) of the strip (2) of support, obtained by transverse cutting of the latter, said part comprising two opposite means (1 1) for gripping the two adjacent ends (21a, 22a) of the two tracks respectively.
8 - assembly of claim 7, characterized in that each means (1 1) for gripping comprises a clamping means (12) one end (21a, 22a) of the strip (2) of support.
9 - assembly of claim 7, characterized in that each means (1 1) comprises gripping means (13) for stapling an end (21a, 22a) of the strip (2) of support, e.g. a pin (13a) to cross the strip with a head (13b) can be snapped onto said pin.
10 - assembly of claim 1, characterized in that the strip (2) comprises an apertured retaining ladderproof knitted fabric obtained with monofilaments or multifilaments of a biocompatible synthetic material, for example polypropylene or polyester.
1 1 - The assembly of claim 1, characterized in that the retaining strip (2) is made in whole or in part by biological tissue or material, for example collagen. 12 - assembly of claim 1, characterized in that the protective sheath (5) is obtained from a synthetic material with a low coefficient of friction, for example PTFE.
PCT/FR2001/003027 2000-10-05 2001-10-01 Sub-urethral supporting assembly for treating female stress urinary incontinence WO2002028312A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
FR0012750A FR2814939B1 (en) 2000-10-05 2000-10-05 Set soutenement sub-urethral in the treatment of urinary incontinence in women effort
FR00/12750 2000-10-05

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
DE2001615705 DE60115705T2 (en) 2000-10-05 2001-10-01 Support arrangement at the bottom of the ureters in the treatment of incontinence in women
DE2001615705 DE60115705D1 (en) 2000-10-05 2001-10-01 Support arrangement at the bottom of the ureters in the treatment of incontinence in women
JP2002531942A JP3776083B2 (en) 2000-10-05 2001-10-01 Urethra under the support assembly of the time of treatment of stress urinary incontinence in women
EP20010976344 EP1339347B1 (en) 2000-10-05 2001-10-01 Sub-urethral supporting assembly for treating female stress urinary incontinence
US10151982 US6685629B2 (en) 2000-10-05 2002-05-22 Suburethral support assembly in treatment of female urinary stress incontinence

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US10151982 Continuation-In-Part US6685629B2 (en) 2000-10-05 2002-05-22 Suburethral support assembly in treatment of female urinary stress incontinence

Publications (1)

Publication Number Publication Date
WO2002028312A1 true true WO2002028312A1 (en) 2002-04-11

Family

ID=8855050

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/FR2001/003027 WO2002028312A1 (en) 2000-10-05 2001-10-01 Sub-urethral supporting assembly for treating female stress urinary incontinence

Country Status (7)

Country Link
US (1) US6685629B2 (en)
EP (1) EP1339347B1 (en)
JP (1) JP3776083B2 (en)
DE (2) DE60115705D1 (en)
ES (1) ES2254498T3 (en)
FR (1) FR2814939B1 (en)
WO (1) WO2002028312A1 (en)

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US6685629B2 (en) 2004-02-03 grant
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